NCT06543771

Clinical Performance Study of Safety Test ABO Device

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Diagast · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.

Detailed description

According to the regulatory text "Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council" \[2\], 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside"). Regulation 2017/746 (IVDR) on IVDMD has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the Safety Test ABO and ABTest Card® are already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.

Conditions

• Transfusion Reaction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Safety Test ABO and ABTest Card®	Pre transfusional control with the Safety Test ABO device (reference device) and the ABTest Card® device (comparator).

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: France